Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections

NCT ID: NCT01613365

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-05-31

Brief Summary

Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. Vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. These complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. Current management of these complications stands on antibiotics, oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases.

Recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. Previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. These colonizations could act as a major predisposing factor to these postoperative respiratory failures. Because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. This decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. To date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.

Conditions

Infections and Respiratory Infectious

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

chlorhexidine gluconate

Group Type: EXPERIMENTAL

Chlorhexidine Gluconate

Intervention Type: DRUG

Oropharyngeal and nasopharyngeal decontamination with Chlorhexidine Gluconate

placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Oropharyngeal and nasopharyngeal decontamination with placebo

Interventions

Chlorhexidine Gluconate

Oropharyngeal and nasopharyngeal decontamination with Chlorhexidine Gluconate

Intervention Type: DRUG

Placebo

Oropharyngeal and nasopharyngeal decontamination with placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult men and women over 18 years
• Submitted to major pulmonary resections for primary lung cancer or pulmonary metastasis
• Anatomical resections (segmentectomy, lobectomy, pneumonectomy)
• With mediastinal lymph node dissection.
• Patient fit for operation
• After informed consent

• Patients < 18 years
• Pulmonary infectious lesions
• Recent respiratory infections
• Tracheostomy
• Swallow difficulties
• Need for non-invasive ventilation before surgery
• Documented sensibility to Chlorhexidine
• Previous ENT cancer
• Previous thoracic surgery
• Patients with an oral assessment score (OAG) >9

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BERNARD BELAIGUES

Role: STUDY_DIRECTOR

Assistance Publique hôpitaux de Marseille

D'JOURNO BENOIT

Role: PRINCIPAL_INVESTIGATOR

AP HM

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

References

D'Journo XB, Falcoz PE, Alifano M, Le Rochais JP, D'Annoville T, Massard G, Regnard JF, Icard P, Marty-Ane C, Trousse D, Doddoli C, Orsini B, Edouard S, Million M, Lesavre N, Loundou A, Baumstarck K, Peyron F, Honore S, Dizier S, Charvet A, Leone M, Raoult D, Papazian L, Thomas PA. Oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate in lung cancer surgery: a randomized clinical trial. Intensive Care Med. 2018 May;44(5):578-587. doi: 10.1007/s00134-018-5156-2. Epub 2018 Apr 18.

Reference Type: DERIVED

PMID: 29671041 (View on PubMed)

Other Identifiers

2011-24

Identifier Type: OTHER

Identifier Source: secondary_id

2011-004536-63

Identifier Type: -

Identifier Source: org_study_id